BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: SMS SOLID STEM STD SIZE 13

    MDR report key: 11743644 · Received April 29, 2021

    Report

    Report Number
    3005180920-2021-00339
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 29, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030888724
    PMA / PMN Number
    K181693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27.04.2021: LOT 2001930: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUN-2020. EXPIRATION DATE: 2025-06-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: FEW DAYS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY, THE PATIENT REPORTED PAIN DUE TO A FEMORAL FRACTURE. DURING REHABILITATION PERIOD, A SUDDEN MOVEMENT ON A WEAKENED BONE DUE TO NORMAL FEMORAL PREPARATION MAY FAVOUR THE OCCURRENCE OF EARLY FRACTURE. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    1 WEEK AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO A SPIRAL PERIPROSTHETIC FEMUR FRACTURE WHICH OCCURRED WHEN THE PATIENT WENT TO SIT DOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON DID NOT FEEL A NEED TO REVISE THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639269 STEM: SMS SOLID STEM STD SIZE 13 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.36.053 2001930 07630030888724

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention